A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients with Muco-Obstructive Lung Disease

Arrowhead Pharmaceuticals, Inc.0 个研究点目标入组 104 人开始时间: 2023年2月8日最近更新: 2024年9月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Arrowhead Pharmaceuticals, Inc.
入组人数: 104

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Inclusion criteria for Patients with Asthma:
•1. Male or nonpregnant, nonlactating female volunteers
•2. Age 18 to 65 years at Screening
•3. Diagnosis of asthma which must have been confirmed and documented (based on source verifiable medical record) for at least 12 months prior to Screening
•4. Documented treatment with a total daily dose of inhaled corticosteroids =500 mcg
•fluticasone propionate dry powder formulation (or equipotent inhaled corticosteroid) for at least 3 months prior to Screening
•5. Documented treatment with at least 1 additional maintenance asthma controller medication (eg, a long-acting ß2-agonist [LABA], a leukotriene receptor antagonist [LTRA], or a long-acting muscarinic antagonist [LAMA]) for at least 3 months prior to Screening
•6. Prebronchodilator ppFEV1 between 40% and 80% inclusive at Screening, prior to sputum induction
•7. Stable dose of asthma controller medications for at least 28 days prior to Screening
•8. If on allergen-specific immunotherapy, patients must be on a stable maintenance dose for at least 90 days prior to first dose
•9. If on biologic therapy for asthma (eg, anti-IgE, anti-IL5/IL5R, anti-IL4R, or anti-thymic stromal lymphopoietin [TSLP]), patients must be on a stable maintenance dose for at least 16 weeks prior to first dose
•10. Chest x-ray taken at Screening that, according to the Investigator, excludes significant alternative respiratory disease
•11. Able and willing to provide written informed consent prior to the performance of any study-specific procedures
•12. BMI between 18.0 and 35.0 kg/m2 at Screening
•13. A 12-lead ECG at Screening with no abnormalities that may compromise participant’s safety in this study
•14. Nonsmoker (defined as someone who has not smoked a cigarette for at least 6 months) with current nonsmoking status confirmed by urine cotinine at Screening AND previous smoking history prior to 6 months must be <10 pack-years. Subjects may be on nicotine replacement (patch or gum). Nicotine e-cigarettes (vapor) are not permitted. A positive urine cotinine result due to nicotine replacement is acceptable for enrollment at the
•discretion of the PI
•15. Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Subjects must not donate sperm or eggs during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later
•16. Able and willing to comply with all study assessments and adhere to the protocol schedule
•17. Able to produce an induced sputum sample at Screening that meets criteria of acceptable quality
•Inclusion Criteria for patients with COPD:
•1. Male or nonpregnant, nonlactating female
•2. Age 40 to 70 years at Screening
•3. Diagnosis of COPD for at least 12 months prior to Screening, based on source verifiable medical record, confirmed with a post-bronchodilator ratio of FEV1 to FVC < 0.7 at Screening
•4. History of chronic bronchitis elicited on the SGRQ-C at Screening
•5. Current smoker or ex-smoker (meaning >1 year of smoking cessation) with a smoking history of = 10 pack-years
•6. Post-bronchodilator ppFEV1 between 30% and 80% inclusive at Screening, prior to sputum induction
•7. Subjects treated with either single, double, or triple therapy for COPD, as described below:
•a. Single therapy consisting of: long-acting beta agonist (LABA) or long-acti

排除标准

•1. Acute lower respiratory infection or asthma exacerbation within 30 days prior to 1st dose
•2. Acute upper respiratory infection within 7 days prior to 1st dose
•3. Positive COVID-19 test during Screening window
•4. Prior history of bronchial thermoplasty treatment
•5. Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, panic attacks with hyperventilation, or other mimics of asthma
•6. Any concomitant pulmonary disease that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the study drug or interpretation of patient safety or study results (including, but not limited to: interstitial lung disease, cystic fibrosis, lung cancer and tuberculosis). Any concomitant pulmonary disease must be discussed with the Medical
•Monitor during Screening
•7. Known unresolved parasitic infection or prior parasitic infection that has required antiparasitic therapy within 30 days prior to first dose
•8. Any history of organ transplant
•9. HIV infection, as shown by presence of anti-HIV antibodies (seropositive)
•10. Seropositive for HBV or HCV (positive result for anti-HCV antibody must be confirmed with positive HCV RNA test for exclusion)
•11. Uncontrolled hypertension (SBP >150 mmHg or DBP >100 mmHg) at Screening
•12. A history of Torsades de Pointes, ventricular rhythm disturbances (eg, ventricular tachycardia or fibrillation), pathologic sinus bradycardia (<50 bpm with symptoms), heart block (excluding first-degree block, being PR prolongation only), congenital long QT syndrome, new ST segment elevation or depression, or new Q wave on ECG. Participants with a history of atrial arrhythmias should be discussed with the Medical Monitor
•13. A family history of congenital long QT syndrome or unexplained sudden cardiac death
•14. Use of medications known to prolong the QTc interval within 30 days prior to first dose (eg, azithromycin)
•15. Use of theophylline within 30 days prior to first dose
•16. Symptomatic heart failure (per NYHA guidelines), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction <20%), TIA, or CVA within 24 weeks prior to first dose
•17. History of malignancy within the past 2 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively treated malignancies who have no evidence of metastatic disease and >2-year disease-free interval may be entered following approval by the Medical Monitor
•18. History of major surgery within 12 weeks prior to first dose
•19. Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not more than 14 units per week for women and 21 units per week for men (1 unit=150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)
•20. Use of illicit drugs (such as cocaine, PCP) within 1 year prior to Screening or positive urine drug screen at Screening (a urine drug screen deemed positive due to prescription medications or for benzodiazepines, opioids, or marijuana is acceptable and inclusion is at the discretion of the PI). Subjects who smoke or vape prescription THC/marijuana should be discussed with the Medical Monitor
•21. Use of an investigational agent or device within 30 days or 5 half-lives (whichever is longer) prior to first dose or current participation in an investigational study
•22. Blood donation (500 mL) within 7 days prior to first dose. Donat

研究者

发起方

Arrowhead Pharmaceuticals, Inc.

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